Quality Assurance Associate (cur_1_132919@curatelyai.net)

Job Description

Job Description

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Quality Assurance Associate

Location: Morrisville, NC 27560 (Onsite)

Duration: 03 months

Pay rate: $37 hr. on W2 AI 

Job Description: 

Required Qualifications:

• Junior-level candidate with 1+ years of experience.
• Strong interest in Quality Assurance and compliance-related work.
• Document control experience is required and considered a dealbreaker.

Preferred Qualifications:

• Prior experience in a regulated environment and Exposure to regulatory and compliance requirements, including

Success Profile:

• Support QA and document control processes for the project.
• Ensure documentation is maintained accurately and in compliance with regulatory requirements.
• Contribute to quality and compliance initiatives supporting business-critical deliverables.

Job Description:

• Maintain periodic review compliance by communicating and following up with document owners.
• Maintain quality document lifecycle through scanning, storing, and archiving in accordance with the Client QMS.
• Responsible for working and interacting cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities. 
• Ensure that records are kept under CLIA, CAP, NYS, and CA requirements such as attributable, legible, original, contemporaneous, and accurate.
• Review all Quality documents for clarity and alignment within operations.
• Ensure that equipment standards are tested, calibrated, and standardized before patient testing.
• Assist with Lot-to-Lot validations of new reagents.
• May assist with nonconformance investigation and root cause analysis.
• May assist with incoming material review.
• May assist teams on internal audits.
• Other duties as assigned.
• Bachelor’s degree or equivalent related experience within a quality assurance, compliance, document control or similar function of a biotechnology, clinical, or diagnostic laboratory; 
• An advanced degree without experience

Preferred Qualifications:

• 1+ years of QA experience
• ASCP or AMT clinical laboratory scientist certification
• Excellent attention to detail and multitasking skills
• Familiarity with MA & NYS regulations, CAP, and CLIA
• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem-solving with departments and colleagues
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated ability to consistently meet or exceed project deadlines
• Understanding of HIPAA and the importance of privacy of patient data
• Ability to work well under pressure while maintaining a professional demeanor.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.